Ricardo Mingarini Terra1, Jader Joel Machado Junqueira2, Lisete Ribeiro Teixeira3, Francisco Suso Vargas3, Paulo Manuel Pêgo-Fernandes2, Fáabio Biscegli Jatene2. 1. Division of Thoracic Surgery, Heart Institute (InCor), Hospital das Clínicas, University of São Paulo Medical School, São Paulo, Brazil. Electronic address: rmterra@uol.com.br. 2. Division of Thoracic Surgery, Heart Institute (InCor), Hospital das Clínicas, University of São Paulo Medical School, São Paulo, Brazil. 3. Pulmonary Division, Heart Institute (InCor), Hospital das Clínicas, University of São Paulo Medical School, São Paulo, Brazil.
Abstract
STUDY OBJECTIVES: To analyze and compare radiologic lung expansion after talc pleurodesis performed either by videothoracoscopy or chest tube and correlate it with clinical outcome. Secondary end points evaluated were as follows: clinical efficacy; quality of life; safety; and survival. METHODS: Prospective randomized study that included 60 patients (45 women, 15 men; mean age, 55.2 years) with recurrent malignant pleural effusion between January 2005 and January 2008. They were randomized into the following two groups: video-assisted thoracic surgery (VATS) talc poudrage; and talc slurry (TS) administered through a chest tube. Lung expansion was evaluated through chest CT scans obtained 0, 1, 3 and 6 months after pleurodesis. Complications, drainage time, hospital stay, and quality of life (Medical Outcomes Study 36-item short form and World Health Organization quality-of-life questionnaires) were also analyzed. RESULTS: There were no significant differences in preprocedure clinical and pathologic variables between groups. The immediate total (ie, > 90%) lung expansion was observed in 27 patients (45%) and was more frequent in the VATS group (60% vs 30%, respectively; p = 0.027). During follow-up, 71% of the patients showed unaltered or improved lung expansion and 9 patients (15%) needed new pleural procedures (VATS group, 5 recurrences; TS group, 4 recurrences; p = 0.999). No differences were found between groups regarding quality of life, complications, drainage time, hospital stay, and survival. Immediate lung expansion did not correlate with radiologic recurrence, clinical recurrence, or complications (p = 0.60, 0.15, and 0.20, respectively). CONCLUSION:Immediate partial lung expansion was a frequent finding and was more frequent after TS. Nonetheless, no correlation between immediate lung expansion and clinical outcome was found in this study. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NTC00789087.
RCT Entities:
STUDY OBJECTIVES: To analyze and compare radiologic lung expansion after talc pleurodesis performed either by videothoracoscopy or chest tube and correlate it with clinical outcome. Secondary end points evaluated were as follows: clinical efficacy; quality of life; safety; and survival. METHODS: Prospective randomized study that included 60 patients (45 women, 15 men; mean age, 55.2 years) with recurrent malignant pleural effusion between January 2005 and January 2008. They were randomized into the following two groups: video-assisted thoracic surgery (VATS) talc poudrage; and talc slurry (TS) administered through a chest tube. Lung expansion was evaluated through chest CT scans obtained 0, 1, 3 and 6 months after pleurodesis. Complications, drainage time, hospital stay, and quality of life (Medical Outcomes Study 36-item short form and World Health Organization quality-of-life questionnaires) were also analyzed. RESULTS: There were no significant differences in preprocedure clinical and pathologic variables between groups. The immediate total (ie, > 90%) lung expansion was observed in 27 patients (45%) and was more frequent in the VATS group (60% vs 30%, respectively; p = 0.027). During follow-up, 71% of the patients showed unaltered or improved lung expansion and 9 patients (15%) needed new pleural procedures (VATS group, 5 recurrences; TS group, 4 recurrences; p = 0.999). No differences were found between groups regarding quality of life, complications, drainage time, hospital stay, and survival. Immediate lung expansion did not correlate with radiologic recurrence, clinical recurrence, or complications (p = 0.60, 0.15, and 0.20, respectively). CONCLUSION: Immediate partial lung expansion was a frequent finding and was more frequent after TS. Nonetheless, no correlation between immediate lung expansion and clinical outcome was found in this study. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NTC00789087.
Authors: Rahul Bhatnagar; Ramon Luengo-Fernandez; Brennan C Kahan; Najib M Rahman; Robert F Miller; Nick A Maskell Journal: Health Technol Assess Date: 2020-06 Impact factor: 4.014
Authors: Ricardo Mingarini Terra; Daniel Reis Waisberg; José Luiz Jesus de Almeida; Marcela Santana Devido; Paulo Manuel Pêgo-Fernandes; Fabio Biscegli Jatene Journal: Clinics (Sao Paulo) Date: 2012 Impact factor: 2.365